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Non-invasive detection and characterization of cutaneous microvascular defects in patients with atherosclerotic cardiovascular disease using optoacoustic imaging

Non-invasive detection and characterization of cutaneous microvascular defects in patients with atherosclerotic cardiovascular disease using optoacoustic imaging - CVD-RSOM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037748
Enrollment
240
Registered
2025-08-22
Start date
2019-07-15
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25

Interventions

Group 1: RSOM measurements in patients diagnosed with atherosclerotic cardiovascular disease Group 2: RSOM measurements in healthy participants

Sponsors

Lehrstuhl für Biologische Bildgebung, Technische Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Group A: 120 patients diagnosed with atherosclerotic cardiovascular disease (coronary heart disease, carotid atherosclerosis, and peripheral arterial occlusive disease), regardless of age or gender. Group B: 120 age- and gender-matched healthy subjects with no evidence of cardiovascular disease.

Exclusion criteria

Exclusion criteria: a) Refusal to undergo the examination. b) Pregnancy. c) Heavily pigmented skin (leads to significant attenuation of the RSOM signal due to the presence of melanin in the skin). d) Documented or suspected light allergy, light intolerance, contact dermatitis, or particularly sensitive skin. e) Age under 18 years. f) Open or infected wounds at the measurement sites.

Design outcomes

Primary

MeasureTime frame
(A) Is RSOM technology suitable for detecting and quantifying structural and functional microvascular disorders in the skin of patients with atherosclerotic cardiovascular disease?

Secondary

MeasureTime frame
(B) How do RSOM parameters correlate with the severity of atherosclerotic cardiovascular disease and cardiovascular risk profile? (C) How do RSOM parameters correlate with the genetic profile of patients with cardiovascular disease? (D) How do the RSOM parameters correlate with the sonographic findings? (E) How do the RSOM parameters correlate with the O2C findings? (F) How are the RSOM parameters related to the laboratory values (if available)?

Countries

Germany

Contacts

Public ContactUte Chambers

Lehrstuhl für Biologische Bildgebung, Technische Universität München

ute.chambers@tum.de+49 89 3187 43779

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026